By Counterforce Health Team in Qalsody (tofersen) —

Getting Qalsody (Tofersen) Covered by Aetna CVS Health in Michigan: ICD-10, HCPCS J-Code, and Billing Guide

Answer Box: Fast Track to Qalsody Coverage

Aetna CVS Health requires prior authorization for Qalsody (tofersen) in Michigan using specific coding and documentation requirements. Use ICD-10 code G12.21 for ALS diagnosis, HCPCS J-code J1304 for billing, and NDC 64406-0109-01 for drug identification. Submit complete documentation including SOD1 genetic test results, neurologist prescription, and baseline ALSFRS-R scores through Aetna's provider portal. Standard approval takes 10 calendar days; expedited reviews complete within 48-72 hours for urgent cases. If denied, Michigan residents can appeal through DIFS external review within 127 days for binding decisions.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping and Documentation
  3. Product Coding: HCPCS, NDC, and Units
  4. Clean Prior Authorization Request
  5. Frequent Billing Pitfalls
  6. Aetna CVS Health Verification
  7. Michigan Appeal Process
  8. Pre-Submission Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Qalsody (tofersen) is administered intrathecally and processed under the medical benefit, not the pharmacy benefit, for Aetna CVS Health members in Michigan. This distinction is crucial for proper claim routing and reimbursement.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all members Aetna Qalsody Policy
Benefit Type Medical benefit (not pharmacy) Qalsody HCP Guide
Formulary Status Specialty tier with PA CVS Caremark Formulary
Site of Care Hospital outpatient or specialty clinic FDA Label
Age Restriction Adults (≥18 years) FDA Label

The medical benefit pathway means claims are processed through Aetna's medical claims system, not CVS Caremark's pharmacy network. This affects everything from prior authorization submission to billing procedures.

ICD-10 Mapping and Documentation

Primary Diagnosis Code: G12.21 (Amyotrophic Lateral Sclerosis)

Use ICD-10 code G12.21 for all ALS cases, including those with confirmed SOD1 mutations. There is no separate code for SOD1-specific ALS, so G12.21 applies universally.

Required Documentation for G12.21:

  • Clinical notes showing both upper and lower motor neuron signs
  • EMG results supporting ALS diagnosis
  • Neurologist evaluation and diagnosis confirmation
  • SOD1 genetic test results (for Qalsody eligibility)
  • Baseline ALSFRS-R functional rating scale score
Clinician Corner: Document both UMN and LMN findings clearly in your clinical notes. Phrases like "fasciculations in multiple muscle groups" and "hyperreflexia with pathologic reflexes" strengthen the diagnostic coding and reduce audit risk.

The documentation must support the ALS diagnosis per El Escorial criteria to meet Aetna's medical necessity requirements.

Product Coding: HCPCS, NDC, and Units

HCPCS J-Code: J1304

  • Description: "Injection, tofersen, 1 mg"
  • Effective: January 1, 2024
  • Replaces: Previous codes C9157, J3490, J3590

NDC: 64406-0109-01

  • Product: Qalsody 100 mg/15 mL single-use vial
  • Manufacturer: Biogen

Unit Conversion Math:

  • Standard dose: 100 mg per administration
  • J1304 represents 1 mg units
  • Bill 100 units of J1304 per 100 mg dose

Administration Schedule:

  • Loading: 3 doses at 14-day intervals (300 total units)
  • Maintenance: Monthly dosing (100 units per month)
  • Year 1 total: ~1,500 units (if started early in year)

Counterforce Health specializes in helping patients navigate complex specialty drug approvals like Qalsody, turning insurance denials into targeted, evidence-backed appeals by identifying specific denial reasons and crafting point-by-point rebuttals aligned to each plan's rules.

Clean Prior Authorization Request

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Clinic staff)
    • SOD1 genetic test report showing pathogenic mutation
    • Neurologist's prescription and clinical notes
    • Baseline ALSFRS-R score within past 12 months
    • Pulmonary function tests (FVC ≥45% predicted)
    • Current ventilation status (must be non-invasive)
  2. Complete Aetna PA Form (Provider)
  3. Submit via Provider Portal (Clinic staff)
    • Submit through Availity or Aetna provider portal
    • Attach all supporting documentation
    • Request expedited review if medically urgent
  4. Track Status (Provider/Patient)
    • Standard decisions: 10 calendar days
    • Expedited decisions: 48-72 hours
    • Follow up if no response within timeframe
  5. Address Information Requests (Provider)
    • Respond to any additional documentation requests within 48 hours
    • Common requests: updated ALSFRS-R, recent clinic notes, genetic counselor report

Frequent Billing Pitfalls

Common Errors and Fixes:

Error Impact Solution
Using old HCPCS codes Claim rejection Always use J1304 (effective 1/1/2024)
Incorrect unit conversion Payment delays Bill 100 units of J1304 per 100mg dose
Missing SOD1 documentation PA denial Include genetic test report with pathogenic mutation
Pharmacy benefit billing Processing errors Route through medical benefit only
Incomplete ALSFRS-R data Medical necessity denial Provide baseline score within 12 months

Unit Conversion Specifics:

  • Each 100 mg vial = 100 units of J1304
  • Loading dose series = 300 total units over 6 weeks
  • Maintenance dosing = 100 units monthly
  • Never bill fractional units; round to nearest whole number
Tip: The Qalsody Copay Program covers anesthesia and administration costs but excludes lab work, observation charges, and facility fees. Verify eligible services before applying copay assistance.

Aetna CVS Health Verification

Pre-Submission Verification Checklist:

  1. Confirm Patient Eligibility
    • Verify active Aetna coverage through provider portal
    • Check specialty pharmacy benefits (CVS Caremark)
    • Confirm prior authorization requirements
  2. Validate Coding Accuracy
    • Cross-reference J1304 with current HCPCS updates
    • Verify NDC 64406-0109-01 in Aetna formulary
    • Confirm ICD-10 G12.21 supports medical necessity
  3. Review Documentation Completeness
    • SOD1 genetic test with pathogenic variant
    • Neurologist evaluation and prescription
    • Baseline functional assessments (ALSFRS-R)
    • Current ventilation status documentation
  4. Check Submission Method
    • Use Aetna provider portal or approved fax line
    • Attach all required forms and documentation
    • Request delivery confirmation

Michigan Appeal Process

If Aetna denies your Qalsody prior authorization, Michigan residents have strong appeal rights under state law.

Internal Appeal (Aetna)

  • File within 60 calendar days of denial letter
  • Standard review: 30 days for decision
  • Expedited review: 72 hours for urgent cases
  • Maintain services: File within 10 days of denial

External Review (Michigan DIFS)

  • File within 127 days of Aetna's final denial
  • Submit External Review Request to Michigan Department of Insurance and Financial Services
  • Standard review: 21-28 days
  • Expedited review: 72 hours with physician certification
  • Decision is binding on Aetna

Required for External Review:

  • Copy of denial letter from Aetna internal appeal
  • Medical records supporting Qalsody necessity
  • Physician letter stating urgency (for expedited review)
  • Completed DIFS external review form
From our advocates: We've seen Michigan external reviews succeed when the clinical documentation clearly establishes both the SOD1 mutation and functional decline despite standard ALS therapies. Independent medical reviewers often overturn denials when the genetic testing and neurologist's assessment align with FDA labeling requirements.

For assistance with the external review process, contact Michigan DIFS at 877-999-6442 or visit their consumer assistance page.

Pre-Submission Audit Checklist

Before submitting your Qalsody prior authorization:

✓ Patient Information

  • Active Aetna coverage verified
  • Member ID and policy details confirmed
  • Prior authorization form completed in full

✓ Clinical Documentation

  • ICD-10 G12.21 documented with supporting clinical notes
  • SOD1 genetic test showing pathogenic mutation
  • Baseline ALSFRS-R score within 12 months
  • Neurologist prescription with administration plan

✓ Coding Accuracy

  • HCPCS J1304 for tofersen injection
  • NDC 64406-0109-01 for drug identification
  • Correct unit calculation (100 units per 100mg dose)

✓ Submission Details

  • All required attachments included
  • Submitted via approved method (portal/fax)
  • Expedited review requested if medically urgent

✓ Follow-up Plan

  • Tracking system in place for PA status
  • Response timeline documented
  • Appeal strategy prepared if denied

FAQ

How long does Aetna CVS Health prior authorization take for Qalsody in Michigan? Standard prior authorization decisions take 10 calendar days. Expedited reviews for urgent medical situations are completed within 48-72 hours. Submit complete documentation to avoid delays.

What if Qalsody is non-formulary on my Aetna plan? Qalsody is typically covered as a specialty tier medication with prior authorization. If listed as non-formulary, request a formulary exception with medical necessity documentation and genetic test results.

Can I request an expedited appeal in Michigan? Yes. Michigan allows expedited external reviews through DIFS when standard timelines would jeopardize health. Requires physician certification that delay would cause serious harm. Decision within 72 hours.

Does step therapy apply to Qalsody with Aetna? Step therapy typically requires trial of riluzole and/or edaravone before Qalsody approval. However, contraindications or previous failures may waive this requirement with proper documentation.

What happens if my Michigan appeal is denied? After exhausting Aetna's internal appeals and Michigan DIFS external review, you may file complaints with Michigan DIFS for potential regulatory action or seek legal counsel for additional options.

How do I find the current Aetna prior authorization form? Access the most current Qalsody precertification form through Aetna's provider portal or their pharmacy forms section.

Can Counterforce Health help with my Qalsody denial? Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters, plan policies, and clinical notes to craft evidence-backed rebuttals that address specific payer criteria and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual policy terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For questions about Michigan insurance regulations, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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